Senior Principal Regulatory Affairs Specialist

About Balt: Our purpose is to improve the lives of 150,000 patients in 2026. For 45 years, Balt has been leading the way—collaborating with physicians and institutions to develop elegant medical devices. Our products are used by physicians worldwide, with 13 offices in 11 countries. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world’s broadest portfolio of medical devices for stroke. As a premier global neurovascular platform, we are expanding into the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

Why Join Balt? Join a passionate team dedicated to making a difference. Working at Balt means giving meaning to your work. We are a close-knit team with strong mission, vision, and values. Recognition of work, respect, and our multicultural community are key aspects of the employee experience. No matter the country, we take care of you.

About the role

The Sr. Principal Regulatory Affairs Specialist is a seasoned expert responsible for completing and maintaining regulatory approvals/clearances for new and modified medical devices, license renewals, and annual registrations. Serves as a Regulatory representative on specific multi-discipline teams, organizing and leading meetings while acting independently to identify and resolve complex problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with regulatory bodies.

Responsibilities

• Develop and implement global regulatory strategies for complex, high-risk medical devices, including contingency plans.
• Represent Regulatory Affairs on project teams and partner with cross-functional teams to ensure alignment of regulatory strategies and organizational objectives.
• Write, review, and file regulatory submissions and documentation for the US and internationally.
• Support product maintenance for currently marketed products, as necessary.
• Review device labeling for compliance with applicable US and international regulations.
• Review product and manufacturing changes for compliance with applicable regulations.
• Review advertising and promotion to ensure compliance with product claims.
• Document, consolidate, and maintain verbal and written communication with regulatory agencies.
• Identify and evaluate regulatory processes and systems for improvements ensuring compliance.
• Assist with audits and inspections, as needed.
• Perform other duties and responsibilities as assigned.

Requirements

• Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
• Nine (9) or more years of professional regulatory experience.
• Documented experience in preparation of US and EU submissions.
• Experience interfacing with relevant regulatory authorities through all stages of device life cycle.

Skills

• Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications.
• Strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
• Ability to work well in a team environment and under pressure in a dynamic, timeline-driven environment.
• Proficiency in MS Office and Adobe Acrobat software.

Physical Requirements

• Must be able to remain in a stationary position 50% of the time.
• Constantly operate a computer and other office equipment, such as a copy machine, printer, etc.

Work Environment

Working conditions are normal for an office environment.

Pay

$170,000—$200,000 USD